Not yet recruitingNCT07893288Updated Oct 23, 2026

A Study of Single and Combination Lipase Dietary Supplements to Increase Fatty Acid Absorption in Generally Health Adults

A Phase 1/2 interventional study of THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases in Digestive Symptoms, Gastrointestinal Symptoms and Healthy, sponsored by Danisco. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Danisco (part of International Flavors & Fragrances Inc.) · Phase 1/2, Interventional, and Health services research

Updated Oct 23, 2026Newly registeredGo to Updates ↓

Phase: Phase 1/2
Study type: Interventional
Enrollment: 50
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

This study aims to investigate the effect of two digestive enzyme dietary supplements, THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases in supporting the breakdown of fat after a meal. The first dietary supplement, THRIVE4U™ TG Lipase, contains a single lipase while the other, THRIVE4U™ Spectrum Lipases, contains a blend of lipases. Lipase breaks down fats to allow your body to efficiently absorb it from food. Poor digestion of fat can cause gastrointestinal symptoms and can impact quality of life. By improving the digestion of fats from high-fat foods, the lipase(s) may help reduce discomfort and support overall digestive health.

Read the detailed description

This randomized, double-blind, placebo-controlled, dose-ranging Phase I/II clinical trial is designed to evaluate the effects of lipase enzyme formulations as dietary supplements, THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases, on fat digestion and absorption in generally healthy adults with evidence of reduced pancreatic enzyme activity. Participants will have fecal elastase-1 (FE-1) levels consistent with potential mild exocrine pancreatic dysfunction and mild-to-moderate gastrointestinal symptoms.

Dietary fats require digestion by lipase enzymes before they can be absorbed in the small intestine. Variability in digestive enzyme activity may reduce the efficiency of fat digestion in some individuals. The investigational products evaluated in this study are dietary supplements containing microbial lipase formulations intended to support the digestion of dietary fats. THRIVE4U™ TG Lipase contains a lipase enzyme formulation and THRIVE4U™ Spectrum Lipases contains a blend of lipase enzymes. The study will assess the effects of these products on markers of lipid digestion, absorption, and gastrointestinal health.

The study will enroll approximately 50 participants who will be randomized to receive THRIVE4U™ TG Lipase, THRIVE4U™ Spectrum Lipases, or placebo in a 2:2:1 allocation ratio. Participants assigned to either active dietary supplement will receive three ascending dose levels over a 3-week supplementation period, allowing assessment of dose-response effects.

To evaluate lipid digestion and absorption, the study will use a standardized Omega-3 Substrate Absorption Challenge Test (O3-SACT). This approach provides a controlled and reproducible method for assessing the impact of lipase supplementation.

In addition to assessing fatty acid absorption, the study will explore the effects of supplementation on several biological and patient-reported outcomes related to fat digestion. Blood samples will also be collected for lipidomic analyses to evaluate changes in circulating lipid species and provide additional insight into the metabolic effects of enhanced lipid digestion.

Safety and tolerability will be monitored throughout the study through clinical laboratory assessments, vital signs, adverse event reporting, and standardized gastrointestinal symptom assessments. Fecal samples and additional biological specimens may be collected and stored for future exploratory analyses of biomarkers related to digestion, metabolism, and gut health.

The study is intended to generate evidence regarding the efficacy, dose-response characteristics, and safety profile of two microbial lipase formulations. The goal is to assess the effects of THRIVE4U™ TG Lipase and THRIVE4U™ Spectrum Lipases supplementation on markers of fat digestion and absorption, gastrointestinal symptoms, and related health outcomes in adults with potential exocrine pancreatic dysfunction. Results from this study may help inform the development of non-animal-derived digestive enzyme dietary supplements designed to support lipid digestion and nutrient absorption.

Conditions studied

Digestive Symptoms
Gastrointestinal Symptoms
Healthy
Impaired Pancreatic Function

Keywords

THRIVE4U™
THRIVE4U
Lipase
Fatty Acid Absorption
Exocrine Pancreatic Dysfunction

In context

Lead sponsor

Danisco is the lead sponsor of 24 studies on the registry; 2 are open to participants now.

First submitted after Danisco became part of International Flavors & Fragrances Inc..

Browse Danisco studies →All International Flavors & Fragrances Inc. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male and female adults who are between 18 - 65 years of age (inclusive) at the time of signing the informed consent.
Have a BMI range of 18.0 - 29.9 kg/m2 (inclusive)
Weigh no less than 50 kilograms.
Are able to consume all aspects of the O3-SACT.
Are able to consume all standardized in-clinic meals provided.
Are able to consume the assigned study product and study components.
Regularly consumes 3 meals a day.
Have FE-1 levels that are between 100 - 300 μg/g within 12 months of screening.
Have a presence of gastrointestinal (GI) symptoms as confirmed by a GSRS total score between 2 and 5 (inclusive) at screening.
Have hematological, serum, and urine parameters within normal limits or not clinically significant, as determined by the investigator.
Must have suitable veins for repeated venipuncture.
Non-smokers (including nicotine vaping) and have not used any nicotine products (patches, gums, etc.) for > 3 months prior to Visit 2. Non-smoker is defined as someone who does not habitually/regularly use products containing nicotine and willing to abstain for 14 days before Visit 2 until the last procedure.
Agree to fast overnight, i.e., no food or liquids (except for water, permitted up to 15 min prior to dosing) for a minimum of 12 h prior to each post-screening visit.
In otherwise good general health, as deemed by the investigator (based on a review of medical history, vital signs, laboratory safety tests, and physical examination if performed at screening).
Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study (unless required per the restrictions).
Agree, from screening until 30 days (for individuals of CBP) or 90 days (for individuals with the potential to impregnate others) after study product administration, to use acceptable contraceptive methods and have negative pregnancy tests if of CBP.
Agree to follow the restrictions on concomitant treatments.
Agree to follow the restrictions on lifestyle.
Willing and able to agree to the requirements of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Exclusion criteria

Exclusion Criteria:

Individuals of CBP who are pregnant, intending to breastfeed, or intending to conceive at the time of consent and during the study, or demonstrate a positive pregnancy test.
Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients or any of the study components.
Have participant reported Type I diabetes, Type II diabetes, high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or thyroid disease.
Have participant reported current diagnosis of a disease causing chronic or recurrent muscle breakdown (e.g., inflammatory myositis, muscular dystrophy, dermatomyositis)
Have had recent major muscle-related injury within the past 4 weeks prior to screening (e.g., bone fracture, crush injury, deep soft-tissue injury).
Have current symptoms, or symptoms within the past 7 days, of an acute infection (e.g., fever, respiratory symptoms such as persistent cough or difficulty breathing), that may influence study outcomes as assessed by the investigator.
Have participant reported history or current diagnosis of cystic fibrosis.
Have clinically significant abnormal laboratory values at screening, including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 5× ULN, alkaline phosphatase > 2× ULN, estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73 m², urine protein ≥ 30 mg/dL, or International Normalized Ratio (INR) ≥ 1.2.
Have participant reported history of prior gastrointestinal surgery (e.g., gastric bypass, gastrectomy, gastric banding, or other visceral surgery) that may interfere with normal gastrointestinal anatomy or function or confound study results.
Have participant reported history or current diagnosis of eating disorders such as anorexia or bulimia.
Have participant reported history of or current use of any prescribed or non-prescribed medication that could potentially interfere with gastric pH, intestinal motility, or fat absorption, including herbal and dietary supplements and antacids. These medications will be discontinued for a minimum of five times their half-life prior to study product administration.
Have a lifestyle incompatible with the trial, such as adherence to extreme diets (e.g., hypocaloric, ketogenic), participation in intense physical activity exceeding 10 hours per week, or any other lifestyle factors as determined by the investigator.
Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel syndrome, ulcerative colitis, irritable bowel syndrome [mixed, constipation-predominant, diarrhea-predominant], or celiac disease).
Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit.
Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.) that may affect the participant's capability to carry out all procedures of the study at the investigator's discretion.
Major surgery in 3 months prior to screening or planned major surgery during the study.
Have a history of alcohol (more than 14 units per week) or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study.
Current enrollment or past participation in another study with any product(s) with at least one active ingredient within 28 days before Visit 2 or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Health services research
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 50 participants (estimated)

Study arms

Experimental
THRIVE4U™ TG Lipase (TP1)
Study product dosing sequences: Dose Level 1(Low) → Dose Level 2 (Medium) → Dose Level 3 (High)
Dietary Supplement: THRIVE4U™ TG Lipase
Experimental
THRIVE4U™ Spectrum Lipases (TP2)
Study product dosing sequences: Dose Level 1(Low) → Dose Level 2 (Medium) → Dose Level 3 (High)
Dietary Supplement: THRIVE4U™ Spectrum Lipases
Placebo comparator
Placebo
Same dose throughout
Dietary Supplement: Placebo

Interventions

Dietary supplementTHRIVE4U™ TG Lipase
THRIVE4U™ TG Lipase is a microbial-derived lipase enzyme supplement administered orally with meals. Participants receive ascending dose levels of low, medium, and high of lipase activity over a 3-week supplementation period (1 week of supplementation for each dose).
Dietary supplementTHRIVE4U™ Spectrum Lipases
THRIVE4U™ Spectrum Lipases is a microbial-derived lipase blend administered orally with meals. Participants receive ascending dose levels of low, medium, and high of lipase activity over a 3-week supplementation period (1 week of supplementation for each dose).
Dietary supplementPlacebo
Matching placebo capsules administered orally with meals. Placebo capsules are identical in appearance to the active study products but contain no active lipase enzyme.

What researchers measure

Primary outcomes

To evaluate the dose-response effect of THRIVE4U™ TG Lipase (TP1) and THRIVE4U™ Spectrum Lipases (TP2) on increasing fatty acid absorption across ascending dose levels within each TP group after a single dose
Plasma concentrations EPA as assessed by the O3-SACT
Time frame: Day 1 of each dose level within each TP group and controlled by baseline challenge
To evaluate the dose-response effect of TP1 and TP2 on increasing fatty acid absorption across ascending dose levels within each TP group after a single dose
Plasma concentrations DHA as assessed by the O3-SACT
Time frame: Day 1 of each dose level within each TP group and controlled by baseline challenge
To evaluate the dose-response effect of TP1 and TP2 on increasing fatty acid absorption across ascending dose levels within each TP group after a single dose
Plasma concentrations total fatty acid profile as assessed by the O3-SACT
Time frame: Day 1 of each dose level within each TP group and controlled by baseline challenge
To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose
Plasma concentrations of EPA as assessed by the O3-SACT
Time frame: Day 1 of each dose level between TP and placebo and controlled by baseline challenge
To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose
Plasma concentrations of DHA as assessed by the O3-SACT
Time frame: Day 1 of each dose level between TP and placebo and controlled by baseline challenge
To evaluate the effects TP1 and TP2 on increasing fatty acid absorption at different dose levels compared to placebo after a single dose
Plasma concentrations of the total fatty acid profile as assessed by the O3-SACT
Time frame: Day 1 of each dose level between TP and placebo and controlled by baseline challenge

Secondary outcomes

To evaluate the effects of TP1 and TP2 on heartburn across ascending dose levels within each TP group and at different dose levels compared to placebo after 7 days of supplementation
The average severity of heartburn episodes, assessed by the Four-Graded Scale. Heartburn severity will be assessed using the mean score over the last 7 days. * None = 0, no symptoms * Mild = 1, awareness of symptoms, but easily tolerated * Moderate = 2, discomfort sufficient to cause interference with normal activities * Severe = 3, incapacitating, with inability to perform normal activities
Time frame: Heartburn severity will be assessed at baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)
To evaluate the effects of TP1 and TP2 on digestive discomfort within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Gastrointestinal Symptom Rating Scale (GSRS) subscale scores for diarrhea, abdominal pain, indigestion, and constipation. Individual subscale items are rated using a 7-point Likert scale. Subscale scores are calculated by taking the average ratings of the applicable items: * Diarrhea: items 11, 12 and 14 * Abdominal pain: items 1, 4 and 5 * Indigestion: items 6, 7, 8 and 9 * Constipation: items 10, 13 and 15 Higher subscales scores and individual item ratings indicate greater symptom severity.
Time frame: GSRS subscale scores will be assessed at baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)
To evaluate the effects of TP1 and TP2 on quality of life within each TP group and at different dose levels compared to placebo after 7 days of supplementation
PROMIS - Global Health score is a 10-item self-report measure that produces two standardized T-scores, including Global Physical Health and Global Mental Health. Each score is derived from four items selected from the 10-item questionnaire. Scoring uses Item Response Theory. Raw summed scores can also be converted to T-scores using PROMIS lookup tables. The questionnaire is an overall evaluation of one's physical and mental health.
Time frame: PROMIS - Global Health scores will be assessed at baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)
To evaluate the effects of overall exposure to TP1 and TP2 on quality of life over the study period compared to placebo
RAND-36 score is to evaluate the effects of the TPs at different dose levels on quality of life compared to placebo by assessing the change in the scale scores. A higher score indicates better health and well-being.
Time frame: RAND-36 score will be assessed during the pre-dose period (Day -1) and Day 22
To evaluate the effects of TP1 and TP2 on the absorption of fat-soluble vitamins D, A, E, and K within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Change in serum vitamin D25 levels
Time frame: Blood draw will occur during baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)
To evaluate the effects of TP1 and TP2 on the absorption of fat-soluble vitamins D, A, E, and K within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Change in serum vitamin A levels
Time frame: Blood draw will occur during baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)
To evaluate the effects of TP1 and TP2 on the absorption of fat-soluble vitamins D, A, E, and K within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Change in serum vitamin E levels
Time frame: Blood draw will occur during baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)
To evaluate the effects of TP1 and TP2 on the absorption of fat-soluble vitamins D, A, E, and K within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Change in serum vitamin K1 levels
Time frame: Blood draw will occur during baseline (Day 1) and the end of each 1-week dosing period (Day 8, 15, and 22)
To evaluate the effects of TP1 and TP2 on the absorption of Vitamin D within each TP group and at different dose levels compared to placebo after a single dose
Postprandial serum vitamin D3 levels over 8 hours
Time frame: Blood draw will occur during pre-dose period (Day -1), baseline (Day 1), Day 8 and 15
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Blood lipid levels (total cholesterol)
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Blood lipid levels (HDL-C)
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Blood lipid levels (LDL-C)
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipid profile (total cholesterol, HDL-C, LDL-C, and TGs) within each TP group and at different dose levels compared to placebo after 7 days of supplementation
Blood lipid levels (TGs)
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22
To evaluate the effects of TP1 and TP2 on the lipidomic profiles within each TP group and at different dose levels compared to placebo after 7 days of supplementation by assessing the up or down regulation of the signal of lipid species within the plasma
Up or down regulation of the signal intensity of lipid species within the plasma lipidomic profile
Time frame: Blood draw will occur during baseline (Day 1), Day 8, 15, and 22

Other outcomes

To explore changes in individual GSRS items following treatment with TP or placebo
Change from baseline in individual GSRS item ratings within each TP group and between placebo and controlled by baseline challenge
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Vitals)
Vitals (HR in bpm)
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Vitals)
Vitals (BP in mmHg)
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Anthropometrics)
Anthropometrics (weight in kg)
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Anthropometrics)
Anthropometrics (BMI in kg/m\^2)
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (GSRS)
GSRS questionnaire to be administered to assess safety of TP regarding GI symptoms. GSRS subscale and total scores calculated. Subscale scores are calculated by taking the average ratings of the applicable items and the GSRS total score is calculated by taking the average of all 5 subscale scores. The subscales and their applicable items are as follows: * Reflux: items 2 and 3 * Diarrhea: items 11, 12 and 14 * Abdominal pain: items 1, 4 and 5 * Indigestion: items 6, 7, 8 and 9 * Constipation: items10, 13 and 15 Higher subscales scores indicate greater severity and higher total scores indicate greater overall GI discomfort.
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Safety Blood Tests - Chemistry)
Laboratory blood tests - Clinical chemistry parameters include: * Sodium * Potassium * Chloride * Blood urea nitrogen * Creatinine * eGFR * Total protein * Albumin * Globulin * Total bilirubin * Random/Fasted Glucose * ALT * AST * Alkaline phosphatase
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Safety Blood Tests - Hematology)
Laboratory blood tests - Hematology parameters include: * Hemoglobin * Hematocrit * White blood cell count with differentials (neutrophils, eosinophils, basophils, lymphocytes, monocytes) * Red blood cell count * Red cell distribution width * Red blood cell indices (mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration) * Platelet count * Mean platelet volume * Coagulation: INR
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Safety Blood Tests - LD and CK)
Laboratory blood tests - Tissue damage-related markers include: * Lactate dehydrogenase * Creatine kinase
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Safety Blood Tests - Other)
Laboratory blood tests for safety analysis of blood concentrations of hs-CRP, amylase, and lipase
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Urine Analyses)
Urine Analyses: * Aspect and color * Specific gravity * Bilirubin * Protein * Glucose * Ketones * Nitrites * Urobilinogen * pH * Blood * Leukocytes * Microscopy
Time frame: Up to end of study (Day 22) or early termination visit
To assess the safety of TP1 and TP2 (Adverse Events)
All changes in health from the screening visit (day -30 to -2) after consent until end of study visit (day 22 +2) will be assessed to determine whether it is an adverse event or not
Time frame: Up to end of study (Day 22) or early termination visit

Study locations

1 site

Apex Trials
Guelph, Ontario - on N1G 0B4, Canada
- Ann Anton · Contact · aanton@apextrials.com · 519-341-3366
- Mariya Chalaskanova · Contact · mchalashkanova@apextrials.com · 519-546-5359
- Anthony Bier, MD · Principal investigator

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

1 registry update since Sep 25, 2026

Registered

First appeared on the registry. No changes since

Oct 23, 2026

Show all 1 update

Oct 23, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07893288
Lead sponsor: Danisco
Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Responsible party: Sponsor
First posted: Oct 23, 2026
Start date: Oct 2026 (estimated)
Primary completion: Dec 2026 (estimated)
Completion: Dec 2026 (estimated)
Last update: Oct 23, 2026

Study contacts

Jevaneeh Rubio

Contact

jrubio@nutrasource.ca

519-341-3367

Stephanie Recker

Contact

srecker@nutrasource.ca

519-341-3367 Ext. 109

Zamir J Latif, PharmD

study director · International Flavors and Fragrances

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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